Table 1

Major inclusion and exclusion criteria

  • Adults of either gender from 22 to 80 years of age, inclusive

  • Grade 2 or more functional MR per 2D or 3D transthoracic echocardiography

  • Symptomatic (NYHA Class ≥II) heart failure patient with MR

  • Participant undergoing concomitant CABG or aortic valve surgery

  • Normal mitral valve leaflets

  • NYHA Class IV after optimal medical therapy

  • Structural abnormality of the mitral valve

  • High pulmonary artery pressures

  • Severe diastolic dysfunction of the left ventricle on echocardiography

  • Transmural MI within 30 days of enrolment; non-ST segment elevation MI within 7 days of enrolment

  • Previous mitral valve surgery, CABG or other previous cardiac surgery that would preclude proper placement of the BACE

  • Chronic renal failure requiring dialysis